LIEGE, BelgiumóMDxHealth recently signed an agreement with
Celldex Therapeutics for the use of its MGMT Epigenetic Test in a Phase III
rindopepimut study of brain cancer.

MDxHealth's epigenetic MGMT test will be used during
recruitment of a randomized, double-blind Phase III global clinical study of
Celldex's immunotherapeutic vaccine, rindopepimut, in newly diagnosed
glioblastoma multiforme (GBM), an aggressive form of brain cancer. The study
has begun screening patients. Financial terms of the deal were not disclosed.

Rindopepimut is an investigational immunotherapeutic vaccine
that targets the tumor specific molecule called EGFRvIII, a functional variant
of the epidermal growth factor receptor (EGFR).

Groen points out that MDxHealth's epigenetic MGMT test is
able to determine the methylation status of the MGMT promoter gene in
glioblastoma patients, thereby helping to stratify the patient population for
the study.

Brad Miles, a spokesman for Celldex, says MDxHealth proved
to be the right collaborator for the agreement because of its experience with
the epigenetic MGMT prognostic assay.

"This test identifies one factor connected to sensitivity or
resistance to the chemotherapy temozolomide, which is the standard of care for
patients with newly diagnosed glioblastoma," says Miles. "The test will be used
to stratify sensitive and resistant patients on each arm of the randomized
study, assuring that there is an equal balance for prognosis on both arms."

The Phase III rindopepimut study is expected to enroll up to
440 patients to recruit 374 patients with newly diagnosed EGFRvIII-expressing
GBM following gross total resection at more than 150 clinical sites
internationally.

In the study, patients expressing EGFRvIII will be tested
with the epigenetic MGMT prognostic assay to determine methylation status of
the MGMT promoter gene. The MGMT methylation result will be used to ensure that
the two arms of the clinical trial are balanced for the known prognostic
influence of improved overall survival in MGM- methylated individuals.

"Patients with glioblastoma whose tumors are positive for
MGMT gene promoter methylation have demonstrated improved overall survival and
improved progression-free survival when compared to patients with unmethylated
or normally functioning MGMT," Groen notes. "The measure of success will be positive
results from the rindopepimut study. Several biomarkers will be measured prior
to the patient receiving therapy, so providing timely assay results is
essential."

Miles notes that the data from previous studies on
rindopepimut are very promising.

"If the benefit seen against historical controls is again
seen in the randomized study, rindopepimut will be a very important treatment
for these patients," he says. "If the assay is done rapidly and accurately
under this contract, we will be likely to have a positive study."